Senior Director, Clinical Operations

HiTalento TALENTO ApS; Boston (MA); Hybrid; USD 230,000 - 320,000; Full time

Job summary

Hemab Therapeutics is seeking a Senior Director, Clinical Operations to lead operational strategy and execution for one program from early development through pivotal trials. You will own the delivery of global studies, identify risks, and drive recovery plans to maintain timelines while partnering with scientific and medical colleagues.

You will lead teams and external partners, building the governance and framework needed to deliver speed without compromising quality across time zones and hubs.

Qualifications

• Experience leading global clinical ops for biotech/pharma programs.
• Ownership of early-to-late development programs incl. pivotal trials.
• Proven track record in recovering underperforming trials.
• Expertise in ICH-GCP, regulatory requirements, and budgets.

Responsibilities

• Define and execute end-to-end clinical operations strategy for assigned asset.
• Translate strategy into executable plans with critical-path and risk reviews.
• Lead global site activation, recruitment, and enrollment strategies.
• Manage CROs and external partners for performance and budgets.
• Ensure governance, reporting, and trial oversight per ICH-GCP and inspections.
• Lead and develop Clinical Operations teams and cross-functional stakeholders.
• Communicate program risks and recommendations to executive leadership.

Skills

Clinical ops leadership

Global development programs

ICH-GCP compliance

Budget management

CRO performance management

Team leadership & development

Stakeholder management

Strategic planning

Education

Bachelor’s degree in life sciences

Advanced degree preferred (MS/PhD)

Tools

CTMS (e.g., Medidata)

EDC systems

Job description

Location

Boston/Cambridge, MA, USA - Hybrid (minimum 2-3 days per week onsite)

Reporting to

SVP Clinical Operations

About Hemab

Hemab is building preventative treatments for serious, underserved bleeding disorders. These are therapies designed to work with the body's own biology and stop bleeds before they start, instead of treating them after they happen. We're patient-first, science-led and clinical-stage - with a pipeline that takes different scientific approaches to different patient needs.

We went public via our 2026 IPO, and we're scaling across two homes: Cambridge, MA, USA, and Copenhagen, Denmark.

The role

As Senior Director, Clinical Operations, you'll lead operational strategy and execution for one of our programs (either HMB-002 or HMB-003), from early development through pivotal trials. You'll own the delivery of complex global studies, anticipate what could put the program at risk, and make sound decisions when the path forward isn't straightforward.

This is a clinical leadership role with genuine accountability. You'll shape development plans alongside scientific and medical colleagues, lead teams and external partners, and build the structure needed to deliver without losing speed.

What you'll do

• Own end-to-end clinical operations strategy and delivery for one of the assigned assets (either HMB-002 or HMB-003), ensuring studies meet critical milestones, quality expectations and budget commitments.
• Translate development strategy into executable plans, using critical-path analysis, scenario planning and early risk identification to protect timelines.
• Take charge when trials encounter difficulties, diagnosing root causes, evaluating options and driving recovery plans through to resolution.
• Represent Clinical Operations on the Asset Team and Clinical Strategy Subteam, challenging assumptions constructively and bringing evidence-based recommendations to development decisions.
• Lead global site activation, recruitment and enrollment strategies, addressing feasibility and patient-access challenges before they affect delivery.
• Hold CROs and external partners accountable for performance, budgets, forecasts, change orders and agreed deliverables.
• Build practical frameworks for governance, decision-making, reporting and trial oversight, maintaining ICH-GCP compliance and inspection readiness.
• Lead and develop Clinical Operations colleagues, strengthen cross-functional accountability and communicate program risks and recommendations clearly to executive leadership and the Board.

What you'll bring to Hemab

• Substantial clinical operations leadership experience in biotechnology or pharmaceuticals, with accountability for complex global development programs.
• Demonstrated ownership of clinical programs across early and late development, including pivotal studies and challenging enrollment environments.
• Evidence of recovering underperforming trials through sound judgment, scenario planning and decisive execution.
• Strong command of ICH-GCP, global regulatory requirements, clinical trial budgets and CRO performance management.
• Experience leading and developing teams through changing priorities, with the ability to influence senior stakeholders and challenge decisions constructively.
• Ability to move between asset-level strategy and hands-on execution, knowing when to decide, collaborate or escalation.

Nice to have

• Experience in rare diseases, hematology or bleeding disorders, particularly von Willebrand disease, hemophilia or Glanzmann thrombasthenia.
• Experience contributing to BLA/MAA submissions or implementing clinical technologies and innovative trial models.

What to expect, honestly

Hemab is still building a lot of its own structure. Systems here tend to get created as we need them, not handed down in advance. Whoever takes this role will likely build some of their own process instead of inheriting a finished one. We work across two hubs and multiple time zones - bridging that well takes real, deliberate effort. And because we're growing quickly, priorities can shift with less notice than they would at a larger, more established company.

We're still defining parts of our governance, responsibilities and ways of working. You'll help establish what works, sometimes without a complete team or established infrastructure. You'll need to take ownership, ask for help without ego and work across functions and time zones.

At our size, how you work matters as much as your credentials. Good structure should create speed and trust.

Why Hemab

At Hemab, your work ultimately connects back to something simple. People living with serious bleeding disorders get something they've never had before - the chance to prevent a bleed, instead of reacting to one after it happens. You'll be joining at a stage where individual decisions still carry real weight, and where your work can help turn promising science into a preventative treatment that actually reaches patients.

How we treat our people is meant to be an extension of how we think about patients: with care, honesty, and respect. We're still building the consistency to back that up across every hiring process, every time. We'd say that plainly instead of pretending otherwise. If any part of your experience with us falls short of it, tell us.

Hemab builds balanced candidate slates and assesses everyone against a single standard. If you need a reasonable adjustment at any stage of the hiring process, please tell us.

Hemab Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.